The CHMP ( Committee for Medicinal Products for Human Use ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Keytruda, intended as monotherapy for the treatment of advanced ( unresectable or metastatic ) melanoma in adults.
Keytruda will be available as a 50 mg powder for concentrate for solution for infusion. The active substance of Keytruda is Pembrolizumab, an antineoplastic monoclonal antibody that potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
The benefit of Keytruda has been reported in adult patients with advanced ( unresectable or metastatic ) melanoma who were either Ipilimumab naive ( overall survival, hazard ratio HR=0.69, 95%CI: 0.52, 0.90; p-value less than 0.00358; progression-free survival HR=0.58; 95%CI: 0.47, 0.72; p-value less than 0.00001 in comparison to Ipilimumab ) or previously treated with Ipilimumab ( progression-free survival, HR=0.57; 95%CI: 0.45, 0.73; p-value less than 0.0001 in comparison to chemotherapy ).
The most common side effects are diarrhoea, nausea, pruritus, rash, arthralgia and fatigue.
Keytruda is associated with immune-related adverse reactions including pneumonitis, colitis, hepatitis, nephritis, endocrinopathies, uveitis, myositis, pancreatitis, and severe skin reactions.
The full indication is: Keytruda as monotherapy is indicated for the treatment of advanced melanoma in adults. ( Xagena )
Source: European Medicines Agency ( EMA ), 2015